Keratinized Tissue DeficiencyNCT07898735
Applying of Absorbable Dressing (Reso-Pac) on the Palatal Donor Site
A study testing Study Group: Reso-pac in people with Keratinized Tissue Deficiency, run by Damascus University at 1 site in Syria.
Trial summary
The periodontal dressing was applied to the donor site of the free gingival graft on the palate to protect the site, reduce postoperative pain, and improve soft tissue healing in the palatal area. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Keratinized Tissue Deficiency
- What is being tested?
- Study Group: Reso-pac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 22 Mar 2023to 27 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Width of attached gingiva less than 2 mm.
- Patient age between 18 and 30 years.
- Good oral hygiene (Plaque Index < 1).
- Absence of periodontal inflammation in the area and no surgical procedures performed there within the preceding six months.
Who cannot join
- Systemic diseases preventing surgery.
- Diseases and medications affecting healing.
- Cellulose allergy.
- Smokers.
- Pregnant and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Periodontology - Faculty of Dentistry - Damascus University
Damascus
About this study
Official title: Evaluating the Efficacy of Absorbable Dressing (Reso-Pac) on the Palatal Donor Site of Free Gingival Graft (Randomized Controlled Trail)
The periodontal dressing was applied to the donor site of the free gingival graft on the palate to protect the site, reduce postoperative pain, and improve soft tissue healing in the palatal area.
Read the detailed description
Traditional periodontal dressings require mechanical retention within the interdental spaces and lack bioactive agents that promote healing or reduce pain.
In contrast, the adhesive dressing used in the study group adheres to soft tissues and contains bioactive agents that help reduce pain and enhance healing.
- Conditions
- Keratinized Tissue Deficiency
- Being tested
- Control group : Coe-pak, Study Group: Reso-pac
- Keywords
- Free Gingival graft, Donor Site, Periodental Dressing, Mucogingival Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group : Coe-pakOther
- Control group (Coe-Pack): Coe-Pack dressing is applied to the palatal donor site after harvesting the epithelial graft.
Study Group: Reso-pacOther
- Study group (Reso-Pac): Reso-Pac dressing is applied to the palatal donor site after harvesting the epithelial graft.
| Study group | Role | What they receive |
|---|---|---|
| Control group : Coe-Pak | Other | - Control group (Coe-Pack): : Coe-Pak periodontal dressing applied to the palatal donor site immediately after free gingival graft harvesting and maintained for one week. Receives: Other: Control group : Coe-pak |
| Study group : Reso-pac | Other | - Study group (Reso-Pac):Reso-Pac resorbable periodontal dressing applied to the palatal donor site immediately after free gingival graft harvesting and maintained for one week. Receives: Other: Study Group: Reso-pac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome MeasuresTitle: Pain Index
The Visual Analog Scale (VAS) was used to assess patients' pain and discomfort daily for one week following treatment. The patient was given a sheet containing a pain scale on which to record their pain level daily. This scale was divided into 100-millimeter increments; a score of 0 at the left end of the scale indicated no pain, while a score of 100 at the right end indicated unbearable pain.
Measured: Time frame :T1: Day 1 post-surgery , T2 : Day 2 Post-surgery , T3: Day 3 post-surgery , T4: Day 4 post-surgery , T5: Day 5 post-surgery , T6: Day 6 post-surgery, Time Final: Day 7 post-surgery..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start22 Mar 2023
- Primary completion28 Apr 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Keratinized Tissue DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MohamadMonzer AlSabbagh, DDS MSc PhD, Principal investigator, Department of Periodontology - Faculty of Dentistry - Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898735
- Sponsor's protocol ID
- UDDS-2026-Perio-12
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paljevic E, Brekalo Prso I, Hrstic JV, Pezelj-Ribaric S, Persic Bukmir R. Impact of Smoking on the Healing of Apical Periodontitis after Nonsurgical Endodontic Treatment. Eur J Dent. 2024 Feb;18(1):124-130. doi: 10.1055/s-0043-1761451. Epub 2023 Mar 28.
PubMed 36977477Khalil S, Habashneh RA, Alomari S, Alzoubi M. Local application of hyaluronic acid in conjunction with free gingival graft: a randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2165-2174. doi: 10.1007/s00784-021-04197-9. Epub 2021 Oct 8.
PubMed 34623507Raghavan SL, Panneerselvam E, Mudigonda SK, Raja KKVB. Protection of an intraoral surgical wound with a new dressing: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2020 Sep;58(7):766-770. doi: 10.1016/j.bjoms.2020.03.017. Epub 2020 Apr 9.
PubMed 32279888Bahammam S, Chen CY, Ishida Y, Hayashi A, Ikeda Y, Ishii H, Kim DM, Nagai S. Electric and Manual Oral Hygiene Routines Affect Plaque Index Score Differently. Int J Environ Res Public Health. 2021 Dec 12;18(24):13123. doi: 10.3390/ijerph182413123.
PubMed 34948732
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Absorbable Dressing (Reso-Pac) on the Palatal Donor Site of Free Gingival Graft (Randomized Controlled Trail)
- ClinicalTrials.gov ID
- NCT07898735
- Acronym / sponsor ID
- UDDS-2026-Perio-12
- Conditions
- Keratinized Tissue Deficiency
- Keywords
- Free Gingival graft, Donor Site, Periodental Dressing, Mucogingival Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The periodontal dressing was applied to the donor site of the free gingival graft on the palate to protect the site, reduce postoperative pain, and improve soft tissue healing in the palatal area.
Detailed description
Traditional periodontal dressings require mechanical retention within the interdental spaces and lack bioactive agents that promote healing or reduce pain.
In contrast, the adhesive dressing used in the study group adheres to soft tissues and contains bioactive agents that help reduce pain and enhance healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group : Coe-Pak | Other | Other: Control group : Coe-pak- Control group (Coe-Pack): : Coe-Pak periodontal dressing applied to the palatal donor site immediately after free gingival graft harvesting and maintained for one week. |
| Study group : Reso-pac | Other | Other: Study Group: Reso-pac- Study group (Reso-Pac):Reso-Pac resorbable periodontal dressing applied to the palatal donor site immediately after free gingival graft harvesting and maintained for one week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Width of attached gingiva less than 2 mm.
Key exclusion criteria (5 listed)
- Systemic diseases preventing surgery.
- Diseases and medications affecting healing.
- Cellulose allergy.
- Smokers.
- Pregnant and breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control group : Coe-pak- Control group (Coe-Pack): Coe-Pack dressing is applied to the palatal donor site after harvesting the epithelial graft. | Other | Control group : Coe-Pak |
| Study Group: Reso-pac- Study group (Reso-Pac): Reso-Pac dressing is applied to the palatal donor site after harvesting the epithelial graft. | Other | Study group : Reso-pac |
Primary outcome
Outcome MeasuresTitle: Pain Index
Time frame: Time frame :T1: Day 1 post-surgery , T2 : Day 2 Post-surgery , T3: Day 3 post-surgery , T4: Day 4 post-surgery , T5: Day 5 post-surgery , T6: Day 6 post-surgery, Time Final: Day 7 post-surgery..
The Visual Analog Scale (VAS) was used to assess patients' pain and discomfort daily for one week following treatment. The patient was given a sheet containing a pain scale on which to record their pain level daily. This scale was divided into 100-millimeter increments; a score of 0 at the left end of the scale indicated no pain, while a score of 100 at the right end indicated unbearable pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 36977477Paljevic E, Brekalo Prso I, Hrstic JV, Pezelj-Ribaric S, Persic Bukmir R. Impact of Smoking on the Healing of Apical Periodontitis after Nonsurgical Endodontic Treatment. Eur J Dent. 2024 Feb;18(1):124-130. doi: 10.1055/s-0043-1761451. Epub 2023 Mar 28.
- Results publication: PubMed 34623507Khalil S, Habashneh RA, Alomari S, Alzoubi M. Local application of hyaluronic acid in conjunction with free gingival graft: a randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2165-2174. doi: 10.1007/s00784-021-04197-9. Epub 2021 Oct 8.
- Results publication: PubMed 32279888Raghavan SL, Panneerselvam E, Mudigonda SK, Raja KKVB. Protection of an intraoral surgical wound with a new dressing: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2020 Sep;58(7):766-770. doi: 10.1016/j.bjoms.2020.03.017. Epub 2020 Apr 9.
- Results publication: PubMed 34948732Bahammam S, Chen CY, Ishida Y, Hayashi A, Ikeda Y, Ishii H, Kim DM, Nagai S. Electric and Manual Oral Hygiene Routines Affect Plaque Index Score Differently. Int J Environ Res Public Health. 2021 Dec 12;18(24):13123. doi: 10.3390/ijerph182413123.
- Individual participant dataSharing planned: No
Related trials for Keratinized Tissue Deficiency
Not yet recruiting
Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
Keratinized Mucosa Deficiency, Peri-implant Soft Tissue
Recruiting
CTG Versus Collagen Matrix for Peri-Implant Soft Tissue Augmentation
Peri-implant Soft Tissue Deficiency, Insufficient Peri-implant Keratinized Tissue
Recruiting
Pontic Site Development With or Without Fixed Partial Denture
Mucogingival Defects, Pontic Site Development
Recruiting
Adjunctive Keratinized Mucosa Augmentation in Peri-Implantitis
Peri-implantitis, Soft Tissue Augmentation at Dental Implants
Recruiting
3D Digital Assessment of Soft Tissue Changes After Modified FGG
Gingival Recession, Localized, Soft Tissue Volume Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MohamadMonzer AlSabbagh, DDS MSc PhD principal investigator
Department of Periodontology - Faculty of Dentistry - Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group: Reso-pac in people with Keratinized Tissue Deficiency, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome MeasuresTitle: Pain Index (time frame: Time frame :T1: Day 1 post-surgery , T2 : Day 2 Post-surgery , T3: Day 3 post-surgery , T4: Day 4 post-surgery , T5: Day 5 post-surgery , T6: Day 6 post-surgery, Time Final: Day 7 post-surgery..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07898735, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.